Avicanna Obtains Its First Indication-Specific Drug Registration with Trunerox™
13 Fevereiro 2024 - 9:30AM
Avicanna Inc. (“
Avicanna” or the
“
Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a
biopharmaceutical company focused on the development,
manufacturing, and commercialization of plant-derived
cannabinoid-based products is pleased to announce the Company’s
first indication-specific drug registration for Trunerox™ issued by
INVIMA, the Health Authority of Colombia.
“The approval of our first pharmaceutical
product is an exceptionally significant milestone and a major step
towards our long-term vision as a biopharmaceutical company with
the aim to serve patients with unmet medical needs. It is also
rewarding to be able to deliver this medication for such a critical
medical condition at an accessible price through our vertical,”
stated Aras Azadian, CEO.
The Trunerox drug approval (Registro Sanitario
como medicamento) was issued by INVIMA, after a detailed process of
verification of all legal, technical, and pharmacological
requirements were fulfilled in accordance with Decree 677 of 1995
and other applicable regulations. The approval allows Avicanna to
manufacture and commercialize Trunerox in Colombia with approved
indications and claims associated to the treatment for seizures
related to Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).
Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) are two
of the various, rare epileptic disorders classified as epileptic
encephalopathies.
Trunerox is Avicanna’s proprietary oral
formulation with 10% cannabidiol (CBD) and is manufactured with
good manufacturing practices GMP at Altea Farmacéutica in Bogota,
Colombia utilizing CBD manufactured at the Avicanna’s
majority-owned subsidiary Santa Marta Golden Hemp SAS.
About Avicanna Inc.
Avicanna is a commercial-stage international
biopharmaceutical company focused on the advancement and
commercialization of evidence-based cannabinoid-based products for
the global medical and pharmaceutical market segments. Avicanna has
an established scientific platform including R&D and clinical
development that has led to the commercialization of more than
thirty products across various market segments:
- Medical Cannabis &
Wellness Products (RHO
Phyto™): The
formulary offers a diverse range of proprietary formulations
including oral, sublingual, topical, and transdermal deliveries
with varying ratios of cannabinoids and is supported with ongoing
patient, and medical community education. RHO Phyto has been
established as a leading medical brand in Canada and is currently
available nationwide to patients across several medical channels
and continues to expand into new international markets.
- Pharmaceutical Preparations
and Pipeline: Leveraging Avicanna’s
scientific platform, vertical integration, and real-world evidence,
Avicanna has developed an extensive a pipeline of patent-pending
drug candidates that are indication-specific and in various stages
of clinical development and commercialization. These
cannabinoid-based drug candidates look to address unmet medical
needs in the areas of dermatology, chronic pain, and various
neurological disorders. Avicanna’s first pharmaceutical preparation
(Trunerox™) is in the drug registration stage in South
America.
About MyMedi.ca
MyMedi.ca is a medical cannabis care platform
formed with the aim to better serve medical cannabis patients’
needs and enhance the patient journey. MyMedi.ca is operated by
Northern Green Canada Inc and features diverse portfolio of
products and a pharmacist led patient support programs. MyMedi.ca
also provides specialty services to distinct patient groups such as
veterans and collaborating with public and private providers for
adjudication and reimbursement and educational resources to
facilitate the incorporation of medical cannabis into health care
regimens.
SOURCE Avicanna Inc.
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Cautionary Note Regarding Forward-Looking Information
and Statements
This news release contains “forward-looking
information” within the meaning of applicable securities laws.
Forward-looking information contained in this news release may be
identified using words such as, “may”, “would”, “could”, “will”,
“likely”, “expect”, “anticipate”, “believe, “intend”, “plan”,
“forecast”, “project”, “estimate”, “outlook” and other similar
expressions. Although the Company believes that the expectations
and assumptions on which such forward looking information is based
are reasonable, undue reliance should not be placed on the
forward-looking information because the Company can give no
assurance that they will prove to be correct. Actual results and
developments may differ materially from those contemplated by these
statements. Forward-looking information is subject to a variety of
risks and uncertainties that could cause actual events or results
to differ materially from those projected in the forward-looking
information. Such risks and uncertainties include but are not
limited to current and future market conditions, including the
market price of the common shares of the Company, and the risk
factors set out in the Company’s annual information form dated
March 31, 2023 filed with the Canadian securities regulators and
available under the Company’s profile on SEDAR at www.sedar.com.
The statements in this news release are made as of the date of this
release. The Company disclaims any intent or obligation to update
any forward-looking information, whether as a result of new
information, future events or results or otherwise, other than as
required by applicable securities laws.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/44fa3fd6-5819-4310-8905-2c8c38ee6d1b
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